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Bruton's Tyrosine Kinase (BTK) Inhibitor

Tolebrutininb for Myasthenia Gravis (URSA Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 27 up to an additional 35 weeks in the ole period until the study termination (i.e., up to week 61)
Awards & highlights

URSA Trial Summary

This trial is testing a new drug, tolebrutinib, to see if it is better than a placebo at treating moderate to severe myasthenia gravis (MG). The trial will last for 2 years and will involve 7 site visits during the first 26 weeks (double-blind treatment period) and quarterly visits during the open label extension period.

Eligible Conditions
  • Myasthenia Gravis

URSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 27 up to an additional 35 weeks in the ole period until the study termination (i.e., up to week 61)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 27 up to an additional 35 weeks in the ole period until the study termination (i.e., up to week 61) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DB Period: Change From Baseline in Myasthenia Gravis-activities of Daily Living (MG-ADL) Total Score at Week 26
OLE Period: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events Leading to Permanent Study Intervention Discontinuation and Adverse Events of Special Interests (AESIs)
OLE Period: Number of Participants With Clinical Chemistry Parameter Abnormalities
+3 more
Secondary outcome measures
DB Period: Change From Baseline in Myasthenia Gravis Impairment Index (MGII) Total Score at Week 26
DB Period: Change From Baseline in Myasthenia Gravis-quality of Life 15-item Scale (MG-QoL15) Total Score at Week 26
DB Period: Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 12
+15 more

URSA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tolebrutinib/TolebrutinibExperimental Treatment1 Intervention
Participants with moderate-to-severe gMG received tolebrutinib 60 mg tablet orally once daily as an add-on therapy to their SoC for 26 weeks in the DB treatment period. Participants who completed the DB period entered the OLE period and continued to receive tolebrutinib 60 mg orally daily along with SoC starting from Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61).
Group II: Placebo/TolebrutinibPlacebo Group2 Interventions
Participants with moderate-to-severe gMG received placebo (matched to tolebrutinib) tablet orally once daily as an add-on therapy to their SoC for 26 weeks in the DB treatment period. Participants who completed the DB period entered the OLE period and received tolebrutinib 60 milligrams (mg) orally daily along with SoC starting from Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61).

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,474 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,293 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Tolebrutininb drug's official standing in America?

"Tolerability has been well documented in Phase 3 trials, therefore our team has given it a score of 3."

Answered by AI

Could you please inform me as to how many different medical facilities are conducting this clinical trial?

"To participate in this trial, you must visit one of the 5 recruiting sites. The centres are located in Tampa, Boca Raton, San Antonio and other cities. To reduce strain, please select the nearest location to you."

Answered by AI

Are octogenarians included in this experimental research?

"The age range for this trial is 18 to 85. There are a total of 72 clinical trials available for patients that fall out of this age bracket, with 12 being for those under 18 and 60 for seniors aged 65 and up."

Answered by AI

To whom is this test available?

"This trial is testing a new medication for myasthenia gravis in patients aged 18 to 85. A total of 154 people are needed for this study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
2021. "Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132569.
~2 spots leftby Apr 2025
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